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Impact of the metho...
Impact of the methotrexate administration dose on the need for intrathecal treatment in children and adolescents with anaplastic large-cell lymphoma: results of a randomized trial of the EICNHL Group.
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Brugières, Laurence (författare)
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Le Deley, Marie-Cécile (författare)
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Rosolen, Angelo (författare)
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Williams, Denise (författare)
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Horibe, Keizo (författare)
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Wrobel, Grazyna (författare)
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Mann, Georg (författare)
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Zsiros, Jozsef (författare)
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Uyttebroeck, Anne (författare)
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- Marky, Ildiko, 1940 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences
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Lamant, Laurence (författare)
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Reiter, Alfred (författare)
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(creator_code:org_t)
- 2009
- 2009
- Engelska.
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Ingår i: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. - 1527-7755. ; 27:6, s. 897-903
- Relaterad länk:
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- PURPOSE: To compare the efficacy and safety of two methotrexate doses and administration schedules in children with anaplastic large-cell lymphoma (ALCL). PATIENTS AND METHODS: This randomized trial for children with ALCL was based on the Non-Hodgkin's Lymphoma-Berlin-Frankfurt-Muenster 90 (NHL-BFM90) study protocol and compared six courses of methotrexate 1 g/m2 over 24 hours and an intrathecal injection (IT) followed by folinic acid rescue at 42 hours (MTX1 arm) with six courses of methotrexate 3 g/m2 over 3 hours followed by folinic acid rescue at 24 hours without IT (MTX3 arm). This trial involved most European pediatric/lymphoma study groups and a Japanese group. RESULTS: Overall, 352 patients (96% ALK positive) were recruited between 1999 and 2005; 175 were randomly assigned to the MTX1 arm, and 177 were assigned to the MTX3 arm. Ninety-two percent of patients received protocol treatment. Median follow-up time is 3.7 years. Event-free survival (EFS) curves were superimposed with 2-year EFS rates (73.6% and 74.5% in the MTX1 and MTX3 arms, respectively; hazard ratio = 0.98; 91.76% CI, 0.69 to 1.38). Two-year overall survival rates were 90.1% and 94.9% in MTX1 and MTX3, respectively. Only two CNS relapses occurred (both in the MTX1 arm). Toxicity was assessed after 2,050 courses and included grade 4 hematologic toxicity after 79% and 64% of MTX1 and MTX3 courses, respectively (P < .0001); infection after 50% and 32% of courses, respectively (P < .0001); and grade 3 to 4 stomatitis after 21% and 6% of courses, respectively (P < .0001). CONCLUSION: The results of the NHL-BFM90 study were reproduced in this large international trial. The methotrexate schedule of the NHL-BFM90 protocol including IT therapy can be safely replaced by a less toxic schedule of methotrexate 3 g/m2 in a 3-hour infusion without IT therapy.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Pediatrik (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Pediatrics (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Immunology in the medical area (hsv//eng)
Nyckelord
- Adolescent
- Antimetabolites
- Antineoplastic
- administration & dosage
- Child
- Child
- Preschool
- Dose-Response Relationship
- Drug
- Drug Administration Schedule
- Female
- Humans
- Infant
- Injections
- Spinal
- Lymphoma
- Large B-Cell
- Diffuse
- drug therapy
- pathology
- Male
- Methotrexate
- administration & dosage
- Treatment Outcome
- Young Adult
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Brugières, Laure ...
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Le Deley, Marie- ...
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Rosolen, Angelo
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Williams, Denise
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Horibe, Keizo
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Wrobel, Grazyna
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visa fler...
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Mann, Georg
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Zsiros, Jozsef
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Uyttebroeck, Ann ...
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Marky, Ildiko, 1 ...
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Lamant, Laurence
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Reiter, Alfred
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visa färre...
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och Klinisk medicin
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och Pediatrik
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- MEDICIN OCH HÄLSOVETENSKAP
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Journal of clini ...
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Göteborgs universitet